CompletedNot Applicable

Photoprotection Efficacy of Different Topical Agents Under Visible Light Exposure

Romania33 participantsStarted 2021-04-23

Plain-language summary

To evaluate the protective effect of seven sunscreens on the pigmentation induced by visible light in comparison to an untreated control zone in healthy volunteers

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy female or male volunteer from 18 to 50 years old
✓. Skin type III-IV according to the Fitzpatrick classification
✓. Average ITA° (Individual Typologic Angle calculated value) on the back between 18° and 32° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits
✓. Uniform skin color over the eight zones (difference in ITA° between each zone should not be more than 4°)
✓. Absence of freckles, naevi, hypo or hyper pigmented regions, hairs and marks of bronzing on the investigational area on the back
✓. Female subject of childbearing potential, who is not sexually active, or using an effective contraceptive method\* for at least one month before the beginning of the study, and throughout the study or menopausal female (with absence of menstruations for less than one year) or post-menopausal female (with absence of menstruations for more than one year)
✓. Female of childbearing potential or menopausal female (with absence of menstruations for less than one year) willing to undergo urine pregnancy test
✓. Subject willing and able to fulfil the study requirements and schedule

Exclusion criteria

✕. Subject who is pregnant or lactating or who is planning to become pregnant during the study
✕. Subject with BMI \> 30
✕. Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study
✕. Having used sunbeds or had excessive sun exposure of the investigational area within the 3 months before inclusion
✕. Having sunburn (erythema) on the back
✕. Having dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems
✕. History of skin cancer
✕. History of abnormal response to sun

What they're measuring

Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)

Timeframe: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).

Trial details

NCT IDNCT06796153

SponsorCosmetique Active International

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-06-18

View on ClinicalTrials.gov More Visible Light Exposure on Healthy Back Skin trials